UDI device identifier

EZ-SHIGELLA One-Step Shigella species Rapid Test 1009-15

UDI device identifier 00083059100952 · BIOMERICA, INC.

Key facts

Primary DI 00083059100952
Brand name EZ-SHIGELLA One-Step Shigella species Rapid Test
Version or model 1009-15
Company BIOMERICA, INC.
DUNS number 067647321
Product code GNB
GMDN term Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jul 1, 2020
Version date Jul 9, 2020
Description The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.

At a glance

  • None MAUDE reports citing this UDI
  • No Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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